What is true regarding IRB approval for the clinical use of a HUD in healthcare?

The statement emphasizes the ongoing responsibilities of a clinician regarding Institutional Review Board (IRB) oversight after the initial approval for the clinical use of a humanitarian use device (HUD). While a HUD may have received initial IRB approval for its use, it is crucial for the clinician to ensure that this approval remains in effect. This typically includes monitoring any changes in the use of the device, any new information that comes to light about its risks, and any potential modifications to the treatment protocol.

Maintaining ongoing IRB approval helps to ensure that patient safety is prioritized throughout the clinical use of the HUD and that the device continues to be used in accordance with the ethical guidelines and regulations put forth by the IRB. Regular communication with the IRB and adherence to their requirements not only supports continuous oversight but also fosters trust and accountability in the clinical research process.